Intelligent Needle Tip Tracking Using Ultrasound Imaging for Lumbar Plexus Blocks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Performance time
研究概览
简要总结
In a randomized controlled crossover study design, ultrasound guided lumbar plexus blocks will be performed with and without the aid of a needle tip tracking (NTT) system. Specialists in anaesthesiology with average experience in ultrasound guided peripheral nerve block (PNB) techniques will perform the blocks. 27 volunteers will be included. The primary objective is to investigate the effect of the NTT system on performance time, as a measure for improved block performance. Secondary objectives are the effects of the NTT system on dexterity, peripheral nerve block characteristics, subjective experience, and peripheral block performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists (ASA) physical status 1 or 2
- •Volunteers that have given informed written consent
排除标准
- •BMI < 18 kg/m2
- •BMI > 35 kg/m2
- •Body weight > 95 kg
- •Volunteers that cannot cooperate during the examination
- •Volunteers that do not speak or understand Norwegian language
- •Volunteers with neurologic disease, nerve- or vascular impairment
- •Volunteers with known coagulopathy
- •Volunteers that are allergic to Lidocaine or other local anaesthetic agents
- •Medications at the investigators discretion
- •Volunteers with concomitant medical treatments interfering with PNB treatment
- •Skin disease or infection affecting the whole-body surface or within the area of examination
- •Any reason why, in the opinion of the investigators, the volunteer should not participate
- •Subject participates in a potentially confounding drug or device trial during the course of the study
- •Pregnancy and lactation period
- •Women of childbearing potential who do not use an effective and secure method for birth control
研究组 & 干预措施
Active needle tip tracking
A needle tip tracking system is used when performing an ultrasound guided lumbar plexus block.
干预措施: Lumbar plexus block using NTT (Procedure)
Inactive needle tip tracking
No needle tip tracking system is used when performing an ultrasound guided lumbar plexus block.
干预措施: Lumbar plexus block without NTT (Procedure)
结局指标
主要结局
Performance time
时间窗: During peripheral nerve block procedure
Performance time is defined as the time from insertion of the block needle (skin puncture) until finishing local anaesthetic (LA) injection
次要结局
- Number of intended movements (needling hand)(During peripheral nerve block procedure)
- Distance travelled by probe hand(During peripheral nerve block procedure)
- Block onset time(Within 30 minutes after peripheral nerve block procedure)
- Block success(30 minutes after peripheral nerve block procedure)
- Quantified discomfort during block performance(Immediately after peripheral nerve block procedure)
- Distance travelled by needling hand(During peripheral nerve block procedure)
- Number of intended movements (probe hand)(During peripheral nerve block procedure)
- Confidence in block success(Immediately after peripheral nerve block procedure)
- Block duration(Within 240 minutes after peripheral nerve block procedure)
研究者
Axel Rudolf Sauter
Pricipal Investigator
Oslo University Hospital